MAUDE Adverse Event Report: SMITH MEDICAL P.A.S. PORT; VENOUS ACCESS SYSTEM

Catalog Number 21-4873-24

Device Problems Material Discolored (1170); Material Integrity Problem (2978)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 05/04/2016

Event Type  malfunction  

Event Description

On (b)(6) 2012 single lumen p.A.S.Port placed and used for 3+ years.Recently has experienced burning and pain when port is accessed, necessitating removal of device.Darkened/black area where white catheter joins the hard device.Product rep will be notified.

• Brand Name: P.A.S. PORT
• Type of Device: VENOUS ACCESS SYSTEM
• Manufacturer (Section D): SMITH MEDICAL; philadelphia PA
• MDR Report Key: 5641275
• MDR Text Key: 44790855
• Report Number: MW5062160
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-4873-24
• Device Lot Number: 2192516
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 92